MedSource Tracheostomy Mask

Basic Information

• Brand Name: MedSource Tracheostomy Mask
• Primary DI: 00840155400306
• Version / Model: MS-25100
• Catalog Number: Not Applicable
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Labeler DUNS: 041674552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-28
• Public Version: 1
• Public Version Date: 2021-06-07
• Public Version Status: New
• Public Device Record Key: 965a6e13-6bb5-490f-a8b3-2df875ad7c9f

Device Description

Tracheostomy Mask, Adult, No Tubing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYG	Mask, Oxygen	Anesthesiology	868.5580	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35179	Tracheostomy mask, aerosol	A device designed to deliver air, oxygen, or a mixture of the two gases with aerosolized water particles to a patient who has a tracheostomy airway. It is typically connected to an oxygen source and nebulizer with wide bore tubing and is constructed of plastic. The device can be used over a tracheostomy tube or a stoma and is secured with a strap. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840155400313	GS1	Case	50	In Commercial Distribution
Primary	00840155400306	GS1